The expanded collaboration provides Biogen with sole decision making and global commercialisation rights for Aduhelm

Eisai_Head_Office

Eisai head office in Tokyo. (Credit: KW at Japanese Wikipedia.)

Biogen and Japanese pharmaceutical firm Eisai have extended their existing collaboration on Alzheimer’s drug aducanumab, which is sold under the brand name Aduhelm, in the US.

Under the expanded partnership, the Japanese drugmaker will receive a tiered royalty based on net sales of Aduhelm, instead of its share in profits and losses, from January next year.

The royalty rate will initially start at 2% and reaches 8% with the annual sales crossing $1bn.

The amended agreement provides Biogen with sole decision making and global commercialisation rights for Aduhelm.

Eisai chief executive officer Haruo Naito said: “The collaboration between both companies has resulted in the approval of Aduhelm in the US as the first treatment to address a defining pathology of Alzheimer’s disease, which is a significant step into a new chapter of Alzheimer’s therapy.

“We believe this new arrangement will be more effective and enable more focused execution with the goal of maximising the value of both ADUHELM and lecanemab.

“Eisai will increase its focus on lecanemab and remains committed to bringing a new treatment option expeditiously to patients in need worldwide.”

In June last year, the US Food and Drug Administration (FDA) approved Aduhelm, despite its failure in one of the two large-scale clinical trials.

Last month, the US Federal Trade Commission and the US Securities and Exchange Commission have ordered Biogen to provide information on the FDA approval of Aduhelm.

In addition to Aduhelm, the two companies would continue to jointly develop and commercialise lecanemab, another of their investigational Alzheimer’s drug

Eisai would continue as the lead the development and regulatory submissions for lecanemab, extending the partnership tenure from five years to 10 years.

Biogen is planning to produce lecanemab drug substance in its manufacturing facility in Solothurn, Switzerland, to provide commercial supply worldwide.

Biogen CEO Michel Vounatsos said: “This amended collaboration agreement will increase operational efficiency and agility in addressing market developments, including the final determination of CMS on coverage of ADUHELM.

“In addition, we are pleased to be expanding our agreement with Eisai through a new long-term manufacturing contract.”